European Medicines Agency issues positive opinion for rivaroxaban

24th July 2017

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on a label update regarding the use of 15mg once-daily of the oral Factor Xa inhibitor rivaroxaban (Xarelto, Bayer) in combination with a P2Y12 inhibitor, for the treatment of patients with non-valvular atrial fibrillation (AF) who require oral anticoagulation and undergo percutaneous coronary intervention (PCI) with stent placement. The final decision of the European Commission is expected by the end of this year.

The positive CHMP opinion is based on data from the Phase IIIb PIONEER AF-PCI study, published in the New England Journal of Medicinein November 2016, which demonstrated that rivaroxaban 15mg once-daily in combination with single antiplatelet therapy significantly reduced the rate of clinically significant bleeding by 41% (relative risk reduction; equivalent to 9.9 percent absolute risk reduction) compared to VKA plus dual antiplatelet therapy (DAPT) through 12 months of randomised therapy in these patients.

The rivaroxaban treatment regimen showed similar rates for the exploratory efficacy endpoint of cardiovascular death, MI, stroke, and stent thrombosis compared to the VKA treatment regimen; however, the study was not powered for statistical significance on efficacy, and therefore no conclusions can be made regarding the efficacy outcomes.

PIONEER AF-PCI is the first randomised study of a NOAC in this patient population. It adds to the extensive investigation of rivaroxaban, which, by the time of its completion, is expected to include more than 275,000 patients in both clinical trials and real-world settings.